Sec. 2122. Susceptibility test interpretive criteria for microorganisms
2,215 words·~10 min read·
/bill/114/hr/6/ih/section-2122A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 511 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360a ) is amended to read as follows: The purpose of this section is to provide the Secretary with an expedited, flexible method for— clearance or premarket approval of antimicrobial susceptibility testing devices utilizing updated, recognized susceptibility test interpretive criteria to characterize the in vitro susceptibility of particular bacteria, fungi, or other microorganisms to antimicrobial drugs; and providing public notice of the availability of recognized interpretive criteria to meet premarket submission requirements or other requirements under this Act for antimicrobial susceptibility testing devices.
The Secretary shall identify appropriate susceptibility test interpretive criteria with respect to antimicrobial drugs— if such criteria are available on the date of approval of the drug under section 505 of this Act or licensure of the drug under section 351 of the Public Health Service Act (as applicable), upon such approval or licensure; or if such criteria are unavailable on such date, on the date on which such criteria are available for such drug. The Secretary shall identify appropriate susceptibility test interpretive criteria under paragraph (2), based on the Secretary’s review of, to the extent available and relevant— preclinical and clinical data, including pharmacokinetic, pharmacodynamic, and epidemiological data;
Bayesian and pharmacometric statistical methodologies; and such other evidence and information as the Secretary considers appropriate. Not later than 1 year after the date of the enactment of the 21st Century Cures Act , the Secretary shall establish, and maintain thereafter, on the website of the Food and Drug Administration, a dedicated website that contains a list of any appropriate new or updated susceptibility test interpretive criteria standards in accordance with paragraph
(2)(referred to in this section as the Interpretive Criteria Website ). The list described in paragraph
(1)shall consist of any new or updated susceptibility test interpretive criteria standards that are— established by a nationally or internationally recognized standard development organization that— establishes and maintains procedures to address potential conflicts of interest and ensure transparent decisionmaking; holds open meetings to ensure that there is an opportunity for public input by interested parties, and establishes and maintains processes to ensure that such input is considered in decisionmaking; and permits its standards to be made publicly available, through the National Library of Medicine or another similar source acceptable to the Secretary; and recognized in whole, or in part, by the Secretary under subsection (c). The Interpretive Criteria Website shall, in addition to the list described in subparagraph (A), include a list of interpretive criteria, if any, that the Secretary has determined to be appropriate with respect to legally marketed antimicrobial drugs, where— the Secretary does not recognize, in whole or in part, an interpretive criteria standard described under subparagraph
(A)otherwise applicable to such a drug; the Secretary withdraws under subsection (c)(1)(B) recognition of a standard, in whole or in part, otherwise applicable to such a drug; the Secretary approves an application under section 505 of this Act or section 351 of the Public Health Service Act, as applicable, with respect to marketing of such a drug for which there are no relevant interpretive criteria included in a standard recognized by the Secretary under subsection (c); or because the characteristics of such a drug differ from other drugs with the same active ingredient, the interpretive criteria with respect to such drug— differ from otherwise applicable interpretive criteria included in a standard listed under subparagraph
(A)or interpretive criteria otherwise listed under this subparagraph; and are determined by the Secretary to be appropriate for the drug. The Interpretive Criteria Website shall include the following: A statement that— the website provides information about the susceptibility of bacteria, fungi, or other microorganisms to a certain drug (or drugs); and the safety and efficacy of the drug in treating clinical infections due to such bacteria, fungi, or other microorganisms may not have been established in adequate and well-controlled clinical trials and the clinical significance of such susceptibility information in such trials is unknown. A statement that directs health care practitioners to consult the approved product labeling for specific drugs to determine the uses for which the Food and Drug Administration has approved the product. Any other statement that the Secretary determines appropriate to adequately convey the limitations of the data supporting susceptibility test interpretive criteria standard listed on the website. Not later than the date on which the Interpretive Criteria Website is established, the Secretary shall publish a notice of that establishment in the Federal Register. The inclusion in the approved labeling of an antimicrobial drug of a reference or hyperlink to the Interpretive Criteria Website, in and of itself, shall not cause the drug to be misbranded in violation of section 502, or the regulations promulgated thereunder. Nothing in this section shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code. Beginning on the date of the establishment of the Interpretive Criteria Website, and at least every 6 months thereafter, the Secretary shall— evaluate any appropriate new or updated susceptibility test interpretive criteria standards established by a nationally or internationally recognized standard development organization described in subsection (b)(2)(A)(i); and publish on the public website of the Food and Drug Administration a notice — withdrawing recognition of any different susceptibility test interpretive criteria standard, in whole or in part; recognizing the new or updated standards; recognizing one or more parts of the new or updated interpretive criteria specified in such a standard and declining to recognize the remainder of such standard; and making any necessary updates to the lists under subsection (b)(2). In evaluating new or updated susceptibility test interpretive criteria standards under paragraph (1)(A), the Secretary may consider— the Secretary’s determination that such a standard is not applicable to a particular drug because the characteristics of the drug differ from other drugs with the same active ingredient; information provided by interested third parties, including public comment on the annual compilation of notices published under paragraph (3); any bases used to identify susceptibility test interpretive criteria under subsection (a)(2); and such other information or factors as the Secretary determines appropriate. Each year, the Secretary shall compile the notices published under paragraph (1)(B) and publish such compilation in the Federal Register and provide for public comment. If the Secretary receives comments, the Secretary will review such comments and, if the Secretary determines appropriate, update pursuant to this subsection susceptibility test interpretive criteria standards— recognized by the Secretary under this subsection; or otherwise listed on the Interpretive Criteria Website under subsection (b)(2). c ) Any susceptibility test interpretive standard recognized under this subsection or any criteria otherwise listed under subsection (b)(2)(B) shall be deemed to be recognized as a standard by the Secretary under section 514(c)(1). Nothing in this section prohibits a person from seeking approval or clearance of a drug or device, or changes to the drug or the device, on the basis of susceptibility test interpretive criteria standards which differ from those recognized pursuant to paragraph (1). With respect to an antimicrobial drug lawfully introduced or delivered for introduction into interstate commerce for commercial distribution before the establishment of the Interpretive Criteria Website, a holder of an approved application under section 505 or section 351 of the Public Health Service Act, as applicable, for each such drug— not later than 1 year after establishment of the Interpretive Criteria Website, shall submit to the Secretary a supplemental application for purposes of changing the drug’s labeling to substitute a reference or hyperlink to such Website for any susceptibility test interpretive criteria and related information; and may begin distribution of the drug involved upon receipt by the Secretary of the supplemental application for such change. With respect to antimicrobial drugs lawfully introduced or delivered for introduction into interstate commerce for commercial distribution on or after the date of the establishment of the Interpretive Criteria Website, the labeling for such a drug shall include, in lieu of susceptibility test interpretive criteria and related information, a reference to such Website. Notwithstanding sections 501, 502, 510, 513, and 515, if the conditions specified in paragraph
(2)are met (in addition to other applicable provisions under this chapter) with respect to an antimicrobial susceptibility testing device described in subsection (f)(1), the Secretary may authorize the marketing of such device for a use described in such subsection. The conditions specified in this paragraph are the following: The device is used to make a determination of susceptibility using susceptibility test interpretive criteria that are— included in a standard recognized by the Secretary under subsection (c); or otherwise listed on the Interpretive Criteria Website under subsection (b)(2). The labeling of such device prominently and conspicuously— includes a statement that— the device provides information about the susceptibility of bacteria and fungi to certain drugs; and the safety and efficacy of such drugs in treating clinical infections due to such bacteria or fungi may not have been established in adequate and well-controlled clinical trials and the clinical significance of such susceptibility information in those instances is unknown; includes a statement directing health care practitioners to consult the approved labeling for drugs tested using such a device, to determine the uses for which the Food and Drug Administration has approved such drugs; and includes any other statement the Secretary determines appropriate to adequately convey the limitations of the data supporting the interpretive criteria described in subparagraph (A). In this section: The term antimicrobial susceptibility testing device means a device that utilizes susceptibility test interpretive criteria to determine and report the in vitro susceptibility of certain microorganisms to a drug (or drugs). The term qualified infectious disease product means a qualified infectious disease product designated under section 505E(d). The term susceptibility test interpretive criteria means— one or more specific numerical values which characterize the susceptibility of bacteria or other microorganisms to the drug tested; and related categorizations of such susceptibility, including categorization of the drug as susceptible, intermediate, resistant, or such other term as the Secretary determines appropriate. The term antimicrobial drug means, subject to subparagraph (B), a systemic antibacterial or antifungal drug that— is intended for human use in the treatment of a disease or condition caused by a bacterium or fungus; may include a qualified infectious disease product designated under section 505E(d); and is subject to section 503(b)(1). If provided by the Secretary through regulations, such term may include— drugs other than systemic antibacterial and antifungal drugs; and biological products (as such term is defined in section 351 of the Public Health Service Act) to the extent such products exhibit antimicrobial activity. Nothing in this section shall be construed— to alter the standards of evidence— under subsection
(c)or
(d)of section 505, including the substantial evidence standard in section 505(d), or under section 351 of the Public Health Service Act (as applicable); or with respect to marketing authorization for devices, under section 510, 513, or 515; to apply with respect to any drug, device, or biological product, in any context other than— an antimicrobial drug; or an antimicrobial susceptibility testing device that uses susceptibility test interpretive criteria to characterize and report the in vitro susceptibility of certain bacteria, fungi, or other microorganisms to antimicrobial drugs in accordance with this section; or unless specifically stated, to have any effect on authorities provided under other sections of this Act, including any regulations issued under such sections. . Section 1111 of the Food and Drug Administration Amendments Act of 2007 (42 U.S.C. 247d–5a; relating to identification of clinically susceptible concentrations of antimicrobials) is repealed. Section 502 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 352 ), as amended by section 2121, is further amended by adding at the end the following: If it is an antimicrobial drug and its labeling fails to conform with the requirements under section 511(d). . Section 514(c)(1)(A) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360d(c)(1)(A) ) is amended by inserting after the Secretary shall, by publication in the Federal Register the following: (or, with respect to susceptibility test interpretive criteria or standards recognized or otherwise listed under section 511, by posting on the Interpretive Criteria Website in accordance with such section) . Not later than two years after the date of enactment of this Act, the Secretary of Health and Human Services shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate a report on the progress made in implementing section 511 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360a ), as amended by this section. Chapter 35 of title 44, United States Code, shall not apply to the collection of information from interested parties regarding the updating of lists under paragraph
(2)of subsection
(b)section 511 of the Federal Food, Drug, and Cosmetic Act (as amended by subsection (a)) and posted on the Interpretive Criteria Website established under paragraph
(1)of such subsection (b). Nothing in this subtitle (including the amendments made by this subtitle) shall be construed to restrict, in any manner, the prescribing or administering of antibiotics or other products by health care practitioners, or to limit the practice of health care.
Connectionstraces to 3
Traces to 3 documents
1 reference not yet in our index
- 42 USC 247d–5a
Citation graph
cites case law
Sec. 2122
Susceptibility test interpretive criteria for microorganisms
Cite42 USC 247d–5a
Cites 4Cited by 0 across 0 sources